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510(k) K123630

FRESENIUS LIBERTY CYCLER by Fresenius Medical Care North America, Design Cente — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2013
Date Received
November 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

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  • K120505 — FRESENIUS 2008T HEMODIALYSIS MACHINE (March 6, 2012)
  • K101715 — FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 (December 21, 2010)

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